Programs and Audits FSVP
FSVP - PROGRAMS AND AUDITS
Under the Food Safety Modernization Act of 2011 (“FSMA”), foreign and domestic food facilities must write and implement Food Safety Plans, and importers in the U.S. are responsible for developing Foreign Supplier Verification Programs to verify the proper implementation of these Food Safety Plans.
Based on my Education, Training and Experience, I am able to perform the necessary “audits” according to the FSVP rule throughout South America, as well as the necessary programs of “Hazard Analysis and Risk-Based Preventive Controls.” And besides, the Food Safety and Quality Organization also can help all of South America with different Qualified Auditors.
Importers covered by the FSVP rule will have to verify that their suppliers meet applicable FDA food safety requirements, including that the food is not adulterated or misbranded concerning allergens.
Demand for food safety audits has surged in recent years in response to an increasingly complex global food supply chain and expanding market requirements for supplier verification. As mandated by the Food Safety Modernization Act (FSMA), new requirements for preventive controls and bolstering the safety of imported food were central themes of several regulations released by the U.S. Food and Drug Administration (FDA), the Preventive Controls and FSVP rules refer to the use of “qualified auditors,” these rules do not require the use of accredited third-party auditors.
Under the Preventive Controls rule, if there is a reasonable probability that an identified hazard will result in serious adverse health consequences or death, then an appropriate supplier verification activity would include on-site audits of the applicable suppliers. According to the rule, a " qualified auditor must perform an on-site supplier audit.”
Both the Preventive Controls and FSVP rules define a “qualified auditor” as a “person who is a qualified individual as defined…[within the rule]…and has technical expertise obtained through education, training or experience (or a combination thereof) necessary to perform the auditing function as required” by the regulations. All applicable training must be documented in records, but FDA is not planning to develop a training curriculum for qualified auditors or minimum standards for competency.
Accredited third-party certification bodies are not required for audits conducted for purposes other than VQIP and mandatory import certification. The Accredited Third-Party Certification rule does not apply to audits to show compliance with industry standards, audits by certification bodies not accredited under FDA’s program or audits conducted as part of a verification program for either the Preventive Controls or FSVP rule.
There are many different types of verification activities that can be used to meet the requirements in the rule. The rule mentions review of the supplier’s relevant food safety records, sampling and testing, and onsite auditing as examples of verification activities that may be appropriate, either individually or in combination. Which activity importers choose should be based on their evaluation of the risk of the food and their supplier’s performance.
The largest foreign suppliers subject to the PC for Human Food rule had to be in compliance in September 2016 with both the PC provisions and the CGMP requirements of that rule, but the largest suppliers subject to the PC for Animal Food rule only had to be in compliance with the CGMP requirements by that date. Therefore, importers of foods from those facilities will only need to consider those provisions of the PC rules that their suppliers have had to come in compliance with by May 30, as well as verify that the food is not adulterated or misbranded concerning allergens.
Also, I want to clarify that importers have some flexibility concerning the PC and produce safety rules. Importers will need to have a program that allows them to demonstrate that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produces rules.
As noted above, importers will have additional time to develop and implement FSVPs for foods from smaller suppliers that are considered qualified facilities or small businesses under the PC rules and for food subject to the produce safety rule.
Which are the most frequent questions? Below are the answers of the FDA.
I already audit my supplier. Can I use that audit as a verification activity?
There are many different types of verification activities that can be used to meet the requirements in the rule. The rule mentions review of the supplier’s relevant food safety records, sampling and testing, and onsite auditing as examples of verification activities that may be appropriate, either individually or in combination. Which activity importers choose should be based on their evaluation of the risk of the food and their supplier’s performance.
If importers determine that an audit is the appropriate verification activity, they must make sure the audit meets the requirements in the rule, namely that the audit considers the FDA food safety requirements that apply, and that the auditor is qualified to perform the audit (e.g., education, training, experience). These requirements are designed to be flexible and various audits currently being used within the industry that may meet our requirements.
What do importers have to verify from foreign suppliers?
Importers covered by the FSVP rule will have to verify that their suppliers meet applicable FDA food safety requirements, including that the food is not adulterated or misbranded concerning allergens.
The largest foreign suppliers subject to the PC for Human Food rule had to be in compliance in September 2016 with both the PC provisions and the CGMP requirements of that rule, but the largest suppliers subject to the PC for Animal Food rule only had to be in compliance with the CGMP requirements by that date. Therefore, importers of foods from those facilities will only need to consider those provisions of the PC rules that their suppliers have had to come in compliance with by May 30, as well as verify that the food is not adulterated or misbranded concerning allergens.
And I want to clarify that importers have some flexibility concerning the PC and produce safety rules. Importers will need to have a program that allows them to demonstrate that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produce rules.
As noted above, importers will have additional time to develop and implement FSVPs for foods from smaller suppliers that are considered qualified facilities or small businesses under the PC rules, as well for food subject to the produce safety rule.
What can importers expect when an investigator reviews their FSVPs?
Remember that, unlike traditional facility inspections, FSVP inspections are based on the review of records, rather than observations of food production. While most of the FSVP inspections will be at the importer’s place of business, we are also going to request that some importers provide FSVP records to FDA electronically, or through other means that delivers the records promptly, as part of a pilot program. In either case, the investigator will ask to view the importer’s FSVP records to determine if there are deficiencies. In most cases, if any deficiencies are found, the importer will be provided an opportunity to correct them. Our focus right now is on supporting compliance, except for problems that pose a danger to health or reflect intentional disregard for legal responsibilities.
I also want to emphasize that we are investing significant resources in training FDA personnel on how to conduct these inspections. Importers can expect an approach that is interactive, and by that I mean that our investigators will be asking questions about what they see and there will be the opportunity for a real dialogue. We encourage importers to keep the lines of communication open with FDA if problems are found. If a corrective action is needed, the importer should communicate clearly what actions will be taken and by what date the corrections will be completed. If problems arise in meeting deadlines, the importer should let us know.
More Information:
https://www.fda.gov/food/guidanceregulation/fsma/ucm361902.htm
Empresas e instituciones con las cuales he colaborado y colaboro.
